FDA Permits Marketing Of New Device Designed To Reduce Sleep Disturbance Related To Nightmares In Certain Adults

The U.S. Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The device provides gentle vibration through a wrist-wearable device, based on an analysis of heart rate and motion during sleep.

The device, called NightWare, is an FDA-compliant medical device using a proprietary application on an Apple Watch that helps people suffering from traumatic nightmares get a more restful night's sleep. It is . . .